About Keystone Compliance

ISTA 7E Temperature Testing

ISTA 7E is the testing standard for thermal transport packaging used in parcel delivery system shipments. The overall goal of the standard is to show the temperature effects incurred during shipping. Essentially, the standard simulates daytime heating and a continuous cooling into night. ISTA 7E testing establishes a qualification tool to assess the ability of an insulated package to protect its contents from temperature variations. The standard qualifies temperature-controlled product packaging for the transportation of potentially temperature sensitive medicine and medicinal products.

The temperature profiles generated for ISTA 7E came from significant field research. ISTA partnered with a packaging supplier, global logistics company and a number of pharmaceutical companies to obtain actual field data. They analyzed shipments across 82 different shipping lanes in the US. The analysis was conducted year-round on roundtrip shipments. The information collected included low temperature, high temperature, temperature variation and the speed of the temperature transition.

The standard has some limitations on its applicability. First, it does not take into account extreme temperature possibilities. The profiles range from a high temperature profile of 30.9 degrees Celsius to a low temperature profile of 1.9 degrees Celsius. Temperatures more extreme than those can be incurred during transportation.

Another limitation of ISTA 7E package testing is the fact that the data came solely from United States shipping lanes. Other areas of the world experience much greater temperature extremes. Plus, the supply chain in the US has some of the more controlled temperatures in the world. It is common for logistics providers to have less control of the temperatures of their packages throughout the rest of the world. For instance, cloth-sided delivery trucks are rare in the United States, but they are common throughout much of Europe.

A third limitation is exposure time. The US supply chain is one of the most efficient in the world. Packages move expeditiously across the country. That does not necessarily happen internationally. Products can be stuck in customs for days or weeks during international shipments. Also, in less-developed countries, delays can occur due to poor transportation networks and a lack of supply of transportation vehicles.

Despite these limitations, ISTA 7E thermal testing provides a significant number of benefits. It provides pharmaceutical and medical manufacturers with independently certified packaging solutions. A manufacturer purchasing an ISTA 7E package or container knows that container meets the industry requirements. Having certified packages to choose from streamlines the time to market and the need for expansive temperature testing. ISTA 7E essentially levels the playing field through this standardization.

As for the actual testing, here are some details of the ISTA 7E transit testing standard. The test samples should be the untested actual package and product. If substitutes are needed, they should be as identical as possible. The package and product are tested together as one. The standard states that packages that have already been exposed to the rigors of transportation cannot be assumed to represent standard conditions. The recommendations are to over package the product for shipment to the ISTA 7E testing lab or re-package the package at the ISTA 7E lab.

The actual temperature profiles in ISTA 7E are for 72- and 144-hour durations. Each profile has specific temperature targets per hour. The temperature tolerance per hour is three degrees Celsius.

Keystone Package Testing is an expert in ISTA 7E testing. Our lab features numerous temperature chambers of various sizes that can accommodate any product. The vast inventory of chambers allows for short lead times on scheduling. We have a team of report writers who thoroughly and expeditiously complete reports. Hundreds of companies partner with Keystone for their testing needs on an annual basis. Contact us to request a quote and experience the benefits of working with Keystone on ISTA 7E testing.